The present invention relates generally to medical apparatus and methods and more particularly to devices and methods for dividing a hollow body organ or otherwise restricting or partitioning a certain section of that organ, particularly a stomach, intestine or gastrointestinal tract for purposes of reducing the volume of the hollow body organ. In addition, such tools and techniques may be used to exclude specified tissue sections within a hollow body organ either to reduce volume, or to exclude the portion of tissue that is clinically undesirable, such as in the case of gastroesophogeal reflux disease (GERD) or exclusion of certain sections of the stomach relating to the nuero hormonal pathways for hunger. These devices may be used alone or in conjunction with each other and may be permanently implanted, or removed once they have served their purpose, e.g., the desired tissue effect has occurred (healing), or the clinical benefit has been achieved, for example, the patient has lost the directed or desired amount of weight, or the patient is no longer experiencing reflux.
In cases of severe obesity, patients may currently undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and/or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the gastrointestinal tract. The procedures currently available include laparoscopic banding, where a device is used to xe2x80x9ctie offxe2x80x9d or constrict a portion of the stomach, vertical banded gastroplasty (VBG), or a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach""s volume and subsequent bypass of the intestine.
Typically, these stomach reduction procedures are performed surgically through an open incision and staples or sutures are applied externally to the stomach or hollow body organ. Such procedures can also be performed laparoscopically, through the use of smaller incisions, or ports, through trocars and other specialized devices. In the case of laparoscopic banding, an adjustable band is placed around the proximal section of the stomach reaching from the lesser curve (LC) of the stomach around to the greater curve (GC), thereby creating a constriction or xe2x80x9cwaistxe2x80x9d in a vertical manner between the esophagus (ES) and the pylorus (PY) (See Prior Art FIG. 1). During a VBG (See Prior Art FIG. 2) a small pouch (P) (approximately 20 cc in volume) is constructed by forming a vertical partition from the gastroesophageal junction (GEJ) to midway down the lesser curvature of the stomach by externally applying staples, and optionally dividing or resecting a portion of the stomach, followed by creation of a stoma (ST) at the outlet of the partition to prevent dilation of the outlet channel and restrict intake. In a Roux-En-Y gastric bypass (see Prior Art FIG. 3), the stomach is surgically divided into a smaller upper pouch connected to the esophageal inflow, and a lower portion, detached from the upper pouch but still connected to the intestinal tract for purposes of secreting digestive juices. A resected portion of the small intestine is then anastomosed using an end-to-side anastomosis to the upper pouch, thereby bypassing the majority of the intestine and reducing absorption of caloric intake and causing rapid xe2x80x9cdumpingxe2x80x9d of highly caloric or xe2x80x9cjunk foodsxe2x80x9d.
Although the outcome of these stomach reduction surgeries leads to patient weight loss because patients are physically forced to eat less due to the reduced size of their stomach, several limitations exist due to the invasiveness of the procedures, including time, general anesthesia, healing of the incisions and other complications attendant to major surgery. In addition, these procedures are only available to a small segment of the obese population (morbid obesity, Body Mass Index xe2x89xa740) due to their complications, leaving patients who are considered obese or moderately obese with few, if any, interventional options.
In addition to surgical procedures, certain tools exist for approximating or otherwise securing tissue such as the stapling devices used in the above-described surgical procedures and others such as in the treatment of gastroesophogeal reflux (GERD). These devices include the GIA(copyright) device (Gastrointestinal Anastomosis device manufactured by Ethicon Endosurgery, Inc. and a similar product by USSC), and certain clamping and stapling devices as described in U.S. Pat. Nos. 5,897,562 and 5,571,116 and 5,676,674, Non-Invasive Apparatus for Treatment of Gastroesophageal Reflux Disease (Bolanos, et al) and U.S. Pat. No. 5,403,326 Method for Performing a Gastric Wrap of the Esophagus for Use in the Treatment of Esophageal Reflux (Harrison et al) for methods and devices for fundoplication of the stomach to the esophagus for treatment of gastro esophageal reflux (GERD). In addition, certain tools as described in U.S. Pat. No. 5,788,715 Telescoping Serial Elastic Band Ligator (Watson et al), U.S. Pat. No. 5,947,983 Tissue Cutting and Stitching Device and Method (Solar et al) detail an endoscopic suturing device that is inserted through an endoscope and placed at the site where the esophagus and the stomach meet. Vacuum is then applied to acquire the adjacent tissue, and a series of stitches are placed to create a pleat in the sphincter to reduce the backflow of acid from the stomach up through the esophagus. These devices can also be used transorally for the endoscopic treatment of esophageal varices (dilated blood vessels within the wall of the esophagus).
Further, certain devices are employed to approximate tissue such as in bowel anastomosis, via traditional suturing or stapling, or employing tools such as the commercially available Valtrac (Devis and Geck Company) and the AKA 2 (see British Journal of Surgery, Vol 87, Iss 8, Page 1071, August 2000), which are circular clamping devices used to affect xe2x80x9ccompression anastomosisxe2x80x9d (e.g. once sufficient clamping force is applied, tissue of the bowel heals together and the device is no longer essential to the joining of the tissue). See also U.S. Pat. No. 5,250,058 Absorbable Anastomotic Fastener Means (Miller et al) and U.S. Pat. No. 5,697,943 Apparatus and Method for Performing Compressional Anastomosis(Sauer et al) and PCT Publication No. WO 99/17662 Anastomosis Ring Insertion Device (Phillips et al).
There is a need for improved devices and procedures. In addition, because of the invasiveness of most of the surgeries used to treat obesity, and the limited success of others, there remains a need for improved devices and methods for more effective, less invasive hollow organ restriction procedures.
The present invention provides for improved methods and apparatus for the transoral, or endoscopic, division of a hollow body organ, such as the creation of a small stomach pouch. In the case of the present invention, the surgeon or endoscopist may insert devices as described below through the patient""s mouth, down the esophagus and into the stomach or intestine as appropriate. The procedure can be performed entirely from within the patient""s stomach or other organ, and does not require any external incision. The end result of the procedure is the formation of a variety of organ divisions or plications that serve as barriers or xe2x80x9cpartitionsxe2x80x9d or xe2x80x9cpouchesxe2x80x9d that are substantially sealed off from the majority of the organ cavity. For example, in the case of dividing the stomach, the xe2x80x9cpouchxe2x80x9d or partitions that are created may seal a small portion of the stomach just below the esophagus to allow only small amounts of food or liquid to be consumed by the patient. This pouch or partition will mimic the section of stomach sealed off from the majority of the organ in a traditional obesity surgery heretofore described; however, it can be formed and secured entirely from inside the stomach endoscopically, obviating the need for a prolonged procedure, external incisions, and in some cases, general anesthesia.
The methods and tools of the present invention may also be used in treating GERD in that stomach folds just below the esophagus can be acquired and fastened to create a desired xe2x80x9cpleatxe2x80x9d, thereby effectively extending the length of the esophagus and preventing reflux. A single fold of tissue, or a dual fold of tissue can be acquired. Further, features of the present invention would assist in the longevity of the GE Junction (GEJ)/Esophageal pleat as compared to current devices and techniques as the plication would include a more significant amount of muscular tissue. In addition, the devices and methods of the present invention may be used to revise or repair failures seen in current surgical procedures, such as dilation of the pouch and/or stoma (stomata) formed in a traditional Roux-En-Y gastric bypass, or VBG. In these cases, when the stoma dilates or shifts, the tools of the present invention would be useful to apply pleats at the site of dilation to narrow it, thereby making the stoma functional again, or by further reducing the volume of an existing pouch which has dilated.
The devices shown and described herein can be used to form a pouch or partition by the approximation and fixation of two folds of organ tissue, one fold created in the anterior wall of the organ, and one fold created in the posterior wall of the organ using a tissue acquisition device inserted minimally invasively or transorally into the target organ, e.g., the stomach. A calibration balloon on the end of the tissue acquisition device may also be employed to size the pouch or partition and to position the tools correctly to determine where the folds will be created. Alternatively, the tissue acquisition device may be adapted to receive a standard endoscope to allow viewing of the target region at various points during the procedure.
The devices shown and described herein can also create the tissue folds using vacuum to acquire tissue from both walls using an endoscopic tissue acquisition device having windows or openings spaced apart from each other, preferably 180 degrees from one another. Once the tissue folds are acquired, an optional mechanical retraction/tensioning mechanism may be employed to engage and tension the folds within the tissue acquisition device. Said mechanical retraction or tensioning mechanism securely approximates the tissue folds such that a consistent and substantial fold of muscular tissue is presented for fixing the tissue folds together.
A fastening element or fastening assembly may also be employed to secure the tissue folds and create the division or divisions within the organ. Additionally, it may be preferable for the fastening assembly to clamp the tissue folds together prior to delivering the fastening elements to enhance the durability of the fastened section.
In similar fashion, a tissue acquisition device may be employed to secure tissue together, either in a dual fold (acquisition of a fold from both the anterior and posterior side of the organ), or single fold configuration (acquisition of one fold of tissue), at the GEJ to create an effective lengthening of the esophagus for treatment of GERD. A single or dual fold of tissue may be acquired at the cardiac notch (portion between the GEJ and the esophagus of the patient) and fastened to form a staple line parallel to the LC of the stomach.
Several aspects of the present invention were arrived at after experimentation with stomach and other body tissue and the challenges of acquiring and securing such tissue reliably. In particular, it is preferable for the device of the present invention to consistently approximate the tissue and tension it such that when the fixation elements or fasteners of the present invention are delivered, they consistently reach the outer fibrous layers of the organ wall, such as the muscularis and serosa of the stomach. Once these fibrous layers are secured appropriately according to the present invention, they will adhere, fuse or scar over to affect the desired fastening of the tissue folds. The devices of the present invention will likely need to maintain apposition of the two folds for 2-4 weeks, but that fusion of the tissue may take place as soon as 5-10 days following the procedure, or as long as 8-10 weeks. If tissue folds are secured inconsistently, or if insufficient compression is applied at the time of securement, complications such as rapid ischemic necrosis, gastric erosion, ulceration, and failure of the secured walls may result.
Various devices and methods for securing the tissue folds once they are approximated, may also include a stapling device, clamp or other fasteners. The fastening assembly may further be a flexible endoscopic stapler device, capable of being deployed within the lumen of the tissue acquisition device once the tissue folds are tensioned, said stapler then rotationally or longitudinally adjusted or automatically aligned within the tissue acquisition device to ensure correct alignment with the tissue folds, and clamped to deploy a staple line. This stapler is preferably deployed with force sufficient to displace much of the mucosal tissue out of the targeted fixation region prior to securing the two tissue folds together. A clamp device may be alternatively deployed instead of a staple to achieve both the clamping function and the fixation function. Said clamp device may include teeth or treads to allow tissue perfusion and cell growth for healing at the fixation region once the clamp is deployed. Fasteners such as rivets or clips may be deployed to secure the tissue.
Any of the fastening devices described herein may be bioabsorbable or biofragmentable, such that once the desired tissue healing has occurred, they dissolve or otherwise degrade leaving only the fixation region, now a tissue xe2x80x9cbridgexe2x80x9d (TB) sufficiently adhered or healed together to maintain the integrity of the pouch or partition, similar in some ways to the compression anastomosis tools referred to above. In addition, they may include coatings or other secondary features to aid healing, such as resorbable meshes, surgical felt, or tissue grafts.
The procedure of the present invention may be permanent in that the pouch or partitions would restrict the stomach indefinitely, or may be reversible (once weight loss is achieved, or reflux minimized) or revised (in the event pouch side needs to be modified). Further, if the physician so desires, techniques of the present invention may be augmented or assisted by the use of other techniques such as laparoscopy. Optionally, techniques of the present invention may be combined with other procedures such as the treatment of GERD or the transoral placement of a bypass prosthesis or other type of liner in the intestine to bypass of the hormonally active portion of the small intestine.